Application of RapidHIT™ ID for cell authentication by fast and convenient STR profiling

Area of Science:

• Biotechnology
• Genetics
• Cellular Biology

Background:

• Cell authentication is critical for cell therapies due to direct in-body administration.
• Short Tandem Repeat (STR) profiling is a standard for human identification and cell authentication.
• Traditional STR profiling methods require extensive time (≥6 hours) and multiple instruments.

Purpose of the Study:

• To propose and validate a method for cell authentication using the RapidHIT™ ID instrument.
• To assess the sensitivity of STR profiling for different cell types and counts with RapidHIT™ ID.
• To evaluate the impact of various pre-treatment and preservation methods on STR profiling results.

Main Methods:

• Utilized four cell types relevant to cell therapy production.
• Compared STR profiling sensitivity across cell types and counts using RapidHIT™ ID.
• Examined effects of preservation solutions, lysis, Proteinase K, FTA cards, and swabs.
• Benchmarked RapidHIT™ ID results against the standard ThermoFisher SeqStudio methodology.

Main Results:

• Achieved high sensitivity in STR profiling with the proposed RapidHIT™ ID method.
• Identified that pre-treatment processes can impact STR profile quality.
• Found that other tested variables (preservation, sample type) had no significant effect on STR profiling outcomes.

Conclusions:

• RapidHIT™ ID offers a significantly faster and simpler alternative for cell authentication.
• The method is suitable for cytology laboratories seeking efficient authentication processes.
• This technology enhances the safety and reliability of cell-based therapies.